NCT03586973

A Phase 2 Study of Cabozantinib in Japanese Participants With Advanced Hepatocellular Carcinoma

A Phase 2, Open-Label, Single-Arm Study of Cabozantinib in Japanese Patients With Advanced Hepatocellular Carcinoma Who Have Received Prior Systemic Anticancer Therapy

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: Takeda · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the efficacy and safety of cabozantinib in Japanese participants with advanced hepatocellular carcinoma (HCC) who have received prior systemic anticancer therapy.

Detailed description

The drug being tested in this study is called Cabozantinib. Cabozantinib is being tested to treat advanced hepatocellular carcinoma in Japanese patients. This study will look at the efficacy and safety of Cabozantinib. The study will enroll approximately 34 patients. Participants will be assigned to Cohort A (at least 17 participants) or Cohort B (approximately 15 participants) and will receive the following treatment. Participants who have received prior sorafenib will enroll to Cohort A and participants who have not received prior sorafenib will enroll to Cohort B. \- Cabozantinib 60 mg All participants will be asked to take one tablet of cabozantinib once daily in the fasted state (dose at least 2 hours after meal and no more food intake for 1 hour postdose) throughout the study. This multi-center trial will be conducted in Japan. The overall time to participate in this study is approximately at most 3 years. Participants will make multiple visits to the clinic during the treatment and posttreatment period, including a follow-up assessment after last dose of study drug.

Conditions

• Advanced Hepatocellular Carcinoma

Interventions

Type	Name	Description
DRUG	Cabozantinib	Cabozantinib tablet

Timeline

• Start date: 2018-08-06
• Primary completion: 2019-07-17
• Completion: 2021-06-29
• First posted: 2018-07-16
• Last updated: 2023-04-18
• Results posted: 2023-04-18

Locations

17 sites across 1 country: Japan